A covid-19 antibody test kit manufactured by Biohit, Hefei, China, and distributed by Virality Diagnostics, New Haven, Conn, has been issued an FDA emergency use authorization. The test is a rapid SARS-CoV-2 lateral flow immunoassay that detects both IgG and IgM antibodies with 98.5% accuracy.
Virality’s diagnostic test will require a simple finger-prick and only one drop of blood, obviating the need for a venous blood draw, and delivers easily interpreted results within 15 minutes. The antibody test measures the body’s immune response to determine whether an individual has produced certain antibodies in response to a SARS-CoV-2 infection, indicating past exposure to and infection by the novel coronavirus.
Recent studies involving over 1,500 patients were conducted at multiple sites, including Yale University and the National Cancer Institute (NCI).1 These studies independently validated that Virality’s tests exhibit 98.8% specificity for the novel coronavirus and 94.9% sensitivity for patients tested at least 2 weeks from symptom onset. Virality has the potential to supply more than a million antibody test kits every day.
For more information, visit Virality Diagnostics.
1. Minteer C, Casanovas-Massana A, LiT, et al. Multi-site validation of a SARS-CoV-2 IgG/IgM rapid antibody detection kit. Preprint. 2020. doi: 10.1101/2020.05.25.20112227. Available at MedRxiv.